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Dynamic Laryngotracheal Separation for Aspiration

This study has suspended participant recruitment.
(Protocol currently reviewed for updating)
Sponsor:
Information provided by:
University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT00580346
First received: December 21, 2007
Last updated: February 17, 2009
Last verified: January 2009
History of Changes
  Purpose

People who aspirate after neurologic insults such as stroke often develop fatal pneumonia. This study examines the effects of dynamic vocal cord closure on swallowing. Implants placed over the chest wall are connected to electrodes placed around the nerve that closes the vocal cords. The patient triggers closure by flipping the switch of a coil taped over the skin covering the internal stimulator. Vocal cord motion is verified by videotaping through an endoscope, and the status of swallowing is documented radiologically by a modified barium swallow.


Condition Intervention Phase
Aspiration Pneumonia
 Device: Placement of laryngeal implant
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Dynamic Laryngotracheal Separation for Aspiration. Prevention of Silent Aspiration Pneumonia During Swallowing by an Implanted Stimulator

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:
  • Videotaping vocal cords and modified barium swallows [ Time Frame: several months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tolerance of implanted device [ Time Frame: immediate to several years ] [ Designated as safety issue: Yes ]
  • comfort in swallowing [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3
Study Start Date: August 2004
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2 Device: Placement of laryngeal implant
Placement of stimulator over anterior chest wall, and electrodes around recurrent laryngeal nerve, and tunneling leads between both
Other Names:
  • Modified Finetech Vocare Bladder stimulator
  • Huntington perineural electrodes

Detailed Description:

Data pending

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aspiration pneumonia after neurological insults (e.g. stroke)
  • Ability to understand the purpose of the research
  • Appropriate hand motor control
  • Inability to improve under standard treatments (speech-language pathologists)
  • Acceptance of a tracheostomy

Exclusion Criteria:

  • Lack of understanding the research
  • Poor hand motor coordination
  • Uncontrolled seizures
  • Pregnancy
  • Refusal to accept a tracheostomy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00580346

Locations
United States, Ohio
University Hospitals Health System
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals of Cleveland
Investigators
Principal Investigator: Michael Broniatowski, MD University Hospitals of Cleveland
  More Information

Publications:

Responsible Party: Michael Broniatowski, MD, University Hospitals of Cleveland health System
ClinicalTrials.gov Identifier: NCT00580346     History of Changes
Other Study ID Numbers: 01-01-02, NIH DC-006703-01, IDE G980179
Study First Received: December 21, 2007
Last Updated: February 17, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by University Hospitals of Cleveland:
Aspiration pneumonia
Implanted laryngeal stimulator
Vocal cord closure
Modified barium swallow

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Aspiration
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on June 17, 2013